Prescription drug · NDA
Sulfatrim (Sulfamethoxazole and trimethoprim) NDC 0121-0854
Sulfamethoxazole 200 mg/5mL; Trimethoprim 40 mg/5mL · Suspension · Oral · PAI Holdings, LLC dba PAI Pharma
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0121-0854-16 | 00121085416 | 473 mL in 1 BOTTLE (0121-0854-16)Marketed from Jul 3, 1983 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Sulfatrim
- Generic name (nonproprietary)
- sulfamethoxazole and trimethoprim
- Active ingredients
- Sulfamethoxazole — 200 mg/5mLTrimethoprim — 40 mg/5mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- PAI Holdings, LLC dba PAI PharmaNDC labeler code 0121
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 018615
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C8 Inhibitors (Mechanism)Cytochrome P450 2C9 Inhibitors (Mechanism)Dihydrofolate Reductase Inhibitors (Mechanism)Organic Cation Transporter 2 Inhibitors (Mechanism)Sulfonamides (Chemical structure)
- Identifiers
- Product ID 0121-0854_a13ce54e-96e8-437a-b4f7-0af852a5a10aSPL ID a13ce54e-96e8-437a-b4f7-0af852a5a10aSPL set ID c62086ea-ba15-40f5-8431-4639c60c9825RxCUI 208406, 313134UNII JE42381TNV, AN164J8Y0X
- Pharmacologic class
- Dihydrofolate Reductase Inhibitor Antibacterial; Sulfonamide Antimicrobial
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400121085416followed by a unit qualifier and the quantityPackage 00121-0854-16. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy. Urinary Tract Infections For the treatment of urinary tract infections due …
Excerpt only. Read the full label for complete information.
About NDC 0121-0854
- What is NDC 0121-0854?
- 0121-0854 is the product NDC for Sulfatrim, Sulfamethoxazole 200 mg/5mL; Trimethoprim 40 mg/5mL suspension, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sulfatrim (Sulfamethoxazole and Trimethoprim).
- What is the active ingredient?
- Sulfamethoxazole, Trimethoprim.
- Who is the labeler?
- PAI Holdings, LLC dba PAI Pharma, NDC labeler code 0121. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sulfatrim?
- 2 other product NDCs are listed under this name. See all Sulfatrim NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sulfatrim products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sulfatrimsulfamethoxazole and trimethoprim | Sulfamethoxazole 200 mg/5mL; Trimethoprim 40 mg/5mL | SuspensionOral | Preferred Pharmaceuticals, Inc. | 68788-7345 | 68788-7345-04 |
| Sulfatrimsulfamethoxazole and trimethoprim | Sulfamethoxazole 200 mg/5mL; Trimethoprim 40 mg/5mL | SuspensionOral | A-S Medication Solutions | 50090-7836 | 50090-7836-00 |
Other NDCs under NDA 018615
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 200 mg/5mL; Trimethoprim 40 mg/5mL | SuspensionOral | PAI Holdings, LLC dba PAI Pharma | 0121-0853 |
| Sulfatrimsulfamethoxazole and trimethoprim | Sulfamethoxazole 200 mg/5mL; Trimethoprim 40 mg/5mL | SuspensionOral | A-S Medication Solutions | 50090-7836 |
| Sulfatrimsulfamethoxazole and trimethoprim | Sulfamethoxazole 200 mg/5mL; Trimethoprim 40 mg/5mL | SuspensionOral | Preferred Pharmaceuticals, Inc. | 68788-7345 |